Ennis & Ennis is dedicated to helping victims of defective and recalled traditional stents as well as the newer drug eluting stents throughout the country. If you or a loved one have been injured as a result of stent malfunction you may be entitled to compensation. For more information about your legal rights or to find out the latest recall information or for a free legal consultation contact our stent injury attorneys today.

- Wall Street Journal

12/14/2007 - The Food and Drug Administration expects to issue new testing requirements in the next few weeks for drug-coated heart stents, the agency's device chief, Daniel Schultz, said.

The revised guidelines come after some researchers have expressed fears that drug-coated stents may cause serious complications. The FDA held a two-day meeting last December over concern that coated stents increase the risk of blood clots years after implantation. After a year of study, it still isn't clear whether they increase late clots, but coated stents don't appear to increase deaths or heart attacks when compared with plain stents.Stents prop open clogged arteries to relieve chest pains from heart disease. Models coated with drugs to reduce reclogging, from Boston Scientific Corp., of Natick, Mass., and Johnson & Johnson, of New Brunswick, N.J., account for most of the U.S. market.The new FDA guidelines, which are expected to be more stringent than those currently in force, will probably cover items such as the numbers of patients on whom new stents must be tested and for how long.

The rules may extend to the periods both before and after the FDA approves a stent for sale to the public. The guidelines may also discuss the recommended time that patients should take the anticlotting drug Plavix after getting a new stent.The FDA's bar for approval can affect how much companies spend on studies as well as the level of certainty doctors and patients can have that stents are safe and effective.

The guidelines aren't expected to affect stents already on the market or models from Minneapolis-based Medtronic Inc. and Abbott Laboratories, of Abbott Park, Ill., that appear to be on the verge of approval.

If you or a loved one have been injured during surgical placement of a stent or have been injured as a result of an implanted drug eluting stent (drug coated stent) such as the Boston Scientific Taxus stent or the Johnson & Johnson Cypher stent you may be entitled to compensation. To learn more about the stent recalls, for information regarding your legal rights, or the possiblilty of a class action lawsuit contact our stent lawyers for a free, confidential, case evaluation today. Fill out our online case evaluation form or call us toll free at 1-800-856-6405.